Melatonin As an Analgesic in Preterm Neonate

Ain Shams University

Status and phase: Completed; Phase 2

Conditions: Preterm Neonate Analgesia

Treatments: Other: Placebo; Drug: Melatonin 10 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05971485

FMASU MS 496/2022

Details and patient eligibility

About

Melatonin (N-acetyl-5-methoxytryptamine) is a neurohormone secreted by the pineal gland with several important functions, including regulation of the circadian rhythms, antioxidant and anti-inflammatory effects, accumulating evidence revealed that it also plays an important role in pain modulation through multiple mechanisms. The investigators aimed to evaluate the analgesic effect of enteral melatonin given 30 minutes before cannula insertion in preterm neonates by assessing Premature Infant pain Profile score (PIPP) before and 5 minutes after the procedure. Additionally, the study aimed to explore the relationship between procedural pain and oxidative stress, along with the effectiveness of pain management of melatonin by measuring Malondialdehyde (MDA), a well-accepted marker of oxidative stress, 60 minutes after the procedure.

Full description

This is a randomized, double-blind, controlled trial

Enrollment: 40 patients

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Preterm infant
• less than 37 weeks gestational age
• who started enteral feeding.

Exclusion criteria

• Multiple congenital anomalies.
• Facial malformation.
• Receiving analgesia or sedation.
• Contraindication of enteral feeding.
• Clinical or laboratory signs of sepsis.
• Infants with high oxygen needs either on invasive or non-invasive mechanical ventilation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Melatonin group

Experimental group

Description:

Preterm neonates will receive melatonin 30 minutes before the venous cannula insertion.

Treatment:

Drug: Melatonin 10 mg

Placebo group

Placebo Comparator group

Description:

Preterm neonates will receive 2 ml of distilled water as a placebo 30 minutes before venous cannula insertion.

Treatment:

Other: Placebo